<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260223141287</udiDi>
    <basicUdiDi>0426022Probes-16B</basicUdiDi>
    <tradeName>ET-12</tradeName>
    <deviceName>Ear Tips for Ear Probes</deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149001</emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100126-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:57.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260223140891</udiDi>
    <basicUdiDi>0426022BoneConductor-2aTS</basicUdiDi>
    <tradeName>BC-RE1</tradeName>
    <deviceName>Bone conductor</deviceName>
    <manufacturerName>PATH MEDICAL GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006935</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100214</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:56.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780104896</udiDi>
    <basicUdiDi>038178B0055CSS3U</basicUdiDi>
    <tradeName>MicroFrance®</tradeName>
    <deviceName>Instrument Holder</deviceName>
    <manufacturerName>Integra MicroFrance</manufacturerName>
    <manufacturerSrn>FR-MF-000011524</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149099</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCL112H</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:28:59.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>10381780097419</udiDi>
    <basicUdiDi>038178B0045CSS3H</basicUdiDi>
    <tradeName>MicroFrance®</tradeName>
    <deviceName>Tension Arm</deviceName>
    <manufacturerName>Integra MicroFrance</manufacturerName>
    <manufacturerSrn>FR-MF-000011524</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149099</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CEV980-3</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:28:46.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195949149948</udiDi>
    <basicUdiDi>0195949HTTV</basicUdiDi>
    <tradeName>00195949149948</tradeName>
    <deviceName>Hearing Test Feature</deviceName>
    <manufacturerName>Apple Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013709</manufacturerSrn>
    <authorisedRepresentativeName>Apple Distribution International Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000012406</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hearing Test Feature 1.X</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:06:00.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049047042396</udiDi>
    <basicUdiDi>4049047ZAO10AFA27DROZJ</basicUdiDi>
    <tradeName>AlphaScope™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gimmi GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E.8187.21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:57.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049047042433</udiDi>
    <basicUdiDi>4049047ZAO10AFA27DROZJ</basicUdiDi>
    <tradeName>AlphaScope™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gimmi GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E.8187.31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:57.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>G644TOC106003BL1</udiDi>
    <basicUdiDi>++G644Otoscopes3F</basicUdiDi>
    <tradeName>Otoscopes</tradeName>
    <deviceName>Otoscopes</deviceName>
    <manufacturerName>Satellite Industries</manufacturerName>
    <manufacturerSrn>PK-MF-000041675</manufacturerSrn>
    <authorisedRepresentativeName>International Business Compendious of Sweden</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000001625</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOC-106-003BL</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:35:06.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G739ZENOAI0102X00L</udiDi>
    <basicUdiDi>++G739ZenoAIYB</basicUdiDi>
    <tradeName>Zeno AI</tradeName>
    <deviceName>Zeno AI</deviceName>
    <manufacturerName>WSK Medical</manufacturerName>
    <manufacturerSrn>NL-MF-000010947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:32:34.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G21550060</udiDi>
    <basicUdiDi>++G21550050FL</basicUdiDi>
    <tradeName>UAMED</tradeName>
    <deviceName>Conventional (Metal Otoscope)</deviceName>
    <manufacturerName>UAMED Surgical Industries</manufacturerName>
    <manufacturerSrn>PK-MF-000029358</manufacturerSrn>
    <authorisedRepresentativeName>Yellow's medical instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007390</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:00:34.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G21550040</udiDi>
    <basicUdiDi>++G21550040FH</basicUdiDi>
    <tradeName>UAMEDConventional (Plastic Head Otoscope)</tradeName>
    <deviceName>Conventional (Plastic Head Otoscope)</deviceName>
    <manufacturerName>UAMED Surgical Industries</manufacturerName>
    <manufacturerSrn>PK-MF-000029358</manufacturerSrn>
    <authorisedRepresentativeName>Yellow's medical instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007390</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:00:31.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G21550030</udiDi>
    <basicUdiDi>++G21550030FE</basicUdiDi>
    <tradeName>UAMEDFiber Optic (Metal Otoscope)</tradeName>
    <deviceName>Fiber Optic (Metal Otoscope)</deviceName>
    <manufacturerName>UAMED Surgical Industries</manufacturerName>
    <manufacturerSrn>PK-MF-000029358</manufacturerSrn>
    <authorisedRepresentativeName>Yellow's medical instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007390</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:00:29.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G21550020</udiDi>
    <basicUdiDi>++G21550020FB</basicUdiDi>
    <tradeName>Fiber Optical Otoscope (Pocket Style)</tradeName>
    <deviceName>Fiber Optical Otoscope (Pocket Style)</deviceName>
    <manufacturerName>UAMED Surgical Industries</manufacturerName>
    <manufacturerSrn>PK-MF-000029358</manufacturerSrn>
    <authorisedRepresentativeName>Yellow's medical instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007390</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:00:28.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>++G21550010</udiDi>
    <basicUdiDi>++G21550010F8</basicUdiDi>
    <tradeName>Fiber Optic Otoscope (Pocket Style)</tradeName>
    <deviceName>Fiber Optic Otoscope (Pocket Style)</deviceName>
    <manufacturerName>UAMED Surgical Industries</manufacturerName>
    <manufacturerSrn>PK-MF-000029358</manufacturerSrn>
    <authorisedRepresentativeName>Yellow's medical instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007390</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149006</emdnCode>
    <emdnDescription>DIRECT OUTPATIENT OTOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:00:28.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>+G739ZENOAI0104X00L</udiDi>
    <basicUdiDi>63057138720299581012RJ</basicUdiDi>
    <tradeName>Zeno AI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>WSK Medical</manufacturerName>
    <manufacturerSrn>NL-MF-000010947</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12149092</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:00:31.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000024270CABINMNMZL</udiDi>
    <basicUdiDi>B-ESMF000024270CABINMNMZL</basicUdiDi>
    <tradeName>DALTE</tradeName>
    <deviceName>cabina insonorizada para audiometrías</deviceName>
    <manufacturerName>MNM INGENIERIA SCA</manufacturerName>
    <manufacturerSrn>ES-MF-000024270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149002</emdnCode>
    <emdnDescription>AUDIOMETRIC CHAMBERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cabina insonorizada</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:26.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ESMF000024270CABINA01TB</udiDi>
    <basicUdiDi>B-ESMF000024270CABINA01TB</basicUdiDi>
    <tradeName>DALTE</tradeName>
    <deviceName>CABINA INSONORIZADA PARA AUDIOMETRÍA</deviceName>
    <manufacturerName>MNM INGENIERIA SCA</manufacturerName>
    <manufacturerSrn>ES-MF-000024270</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149002</emdnCode>
    <emdnDescription>AUDIOMETRIC CHAMBERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A 84(84X84X205CM)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:02:26.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100-54-TLHC</udiDi>
    <basicUdiDi>B-100-54-TLHC</basicUdiDi>
    <tradeName>Surgify Safety Burr</tradeName>
    <deviceName>Surgify Safety Burr</deviceName>
    <manufacturerName>Surgify Medical Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000017137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100-54-TL</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:33:18.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117244335</udiDi>
    <basicUdiDi>5711117_P-0000498_SY</basicUdiDi>
    <tradeName>Sanibel REM Probe Tubes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8602724</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:49:14.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>05711117227574</udiDi>
    <basicUdiDi>5711117_P-0000498_SY</basicUdiDi>
    <tradeName>Sanibel REM Probe Tubes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DGS Diagnostics A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000020570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149085</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8533303</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:49:14.040Z</lastUpdated>
  </row>
</eudamedExport>